Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Persistent Facial Erythema

Phase 3

Withdrawn

• Conditions: Erythema
• Interventions: Drug: CD07805/47 Gel 0.5%; Drug: CD07805/47 Gel Placebo

• Registration Number: NCT01882712
• Lead Sponsor: Galderma R&D

Brief Summary

The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily for 29 days versus vehicle control, in subjects with moderate to severe chronic persistent vascular facial erythema

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-20
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-05
• Last Update Posted: 2014-11-06
• Primary Completion: 2015-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male or female, who is at least 18 years of age or older at screening visit.
• Presence of chronic persistent vascular facial erythema for ≥ 3 months by history.
• A Clinician's Erythema Assessment (CEA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
• A Patient Self Assessment (PSA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1.

Exclusion Criteria

• More than 2 facial inflammatory lesions (papules, pustules, and nodules).
• Presence of areas of significant scaling or crusting on the face.
• Presence of psoriatic lesions on the face.
• Presence of any other dermatological condition of the face that, in the opinion of the Investigator, may significantly interfere with the interpretation of the clinical trial results.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CD07805/47 Gel 0.5%	CD07805/47 Gel 0.5%	active arm
CD07805/47 Gel Placebo	CD07805/47 Gel Placebo	Comparator arm

Primary Outcome Measures

Name	Time	Method
Composite success on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)	Day 29	2-grade improvement on both CEA and PSA at Hours 3, and 6 after Pre-dose (T0)on Day 29

Secondary Outcome Measures

Name	Time	Method
Composite improvement on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)	Day 1	1-grade improvement on both CEA and PSA at 30 minutes after pre-dose (T0) on Day 1